BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPT FEMORAL STEM

    MDR report key: 8018816 · Received October 30, 2018

    Report

    Report Number
    0002648920-2018-00781
    Event Type
    Injury
    Date Received
    October 30, 2018
    Date of Event
    December 19, 2014
    Report Date
    February 12, 2019
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JDI
    PMA / PMN Number
    K960658
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DURING OUR INVESTIGATION IT WAS FOUND THAT THIS EVENT AND ALL AVAILABLE INFORMATION WAS PREVIOUSLY REPORTED ON (B)(4) ON MFR 0002648920-2017-00587. THIS COMPLAINT SHOULD BE VOIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 00801802801 VERSYS FEMORAL HEAD 62282936, 00801102028 ALLEN PLUG 62422110, RM 4901 000 2 COMPETITOR CUP 1401140A, RM 5110 003 2 COMPETITOR LINER 1311178A. EVENT REPORTED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, PRODUCT LOCATION IS UNKNOWN THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 7 MONTHS POST OPERATIVELY DUE TO PERIPROSTHETIC FRACTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858851 CPT FEMORAL STEM PROSTHESIS, HIP JDI ZIMMER MANUFACTURING B.V. N/A 62506602

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R